Thursday, August 15, 2013

AbbVie publishes preliminary results for ABT-414 Phase I study in patients with recurrent or inoperable GBM

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AbbVie publishes preliminary results for ABT-414 Phase I study in patients with recurrent or inoperable GBM -

AbbVie (NYSE: ABBV) published the preliminary results a Phase I ongoing studies with ABT-414, an anti-epidermal growth factor receptor (EGFR), a monoclonal antibody drug conjugate, in combination with temozolomide, which shows four objective response, including complete response in inoperable or recurrent glioblastoma patients. Specifically, one patient had a complete response (CR) and three patients experienced a partial response (PR) measured the revised assessment in Neuro-Oncology (Rano) criteria. These results were presented for the first time at 50 e Annual Meeting of the American Society of Clinical Oncology (ASCO), May 30 - June 3 in Chicago

"Glioblastoma multiforme is the most common type and most aggressive primary malignant brain tumor, and patients have limited treatment options and a five year survival rate of less than 3 percent, "said Gary Gordon, MD Vice President of division, clinical development oncology, AbbVie. "We look forward to ongoing evaluation of this compound in further clinical trials."

Phase I, open, multicenter, international, was designed to assess the toxicity, pharmacokinetics and recommended Phase II dose of ABT - 414 when administered every two weeks in combination with temozolomide in patients with recurrent or inoperable glioblastoma other important assessments included adverse events, pharmacokinetics, biomarkers and objective response of the growth factor receptor. epidermal tumor tissue.

"ABT-414 is designed to release the effects of cytotoxic agent once inside targeted cancer cells," said Gan Hui, medical oncologist and principal investigator at health Institute and Ludwig Austin for Cancer Research, Heidelberg, Australia. "The complete response and three partial responses call for a new evaluation of this compound in this population extremely difficult to treat patients."

Common side effects (> 4 patients) included blurred vision (9 patients), nausea (7 patients), fatigue (6 patients), headache (6 patients), foreign body sensation in the eye (5 patients), photophobia (5 patients), pyrexia (5 patients), corneal deposits (4 patients), eye pain (4 patients) and keratitis (4 patients). Grade 3/4 AEs events (> 2 patients) included keratitis (2 patients). Three dose limiting toxicities were reported, including Grade 3 corneal deposits.

later stage clinical trials are planned to further investigate ABT-414 in patients with glioblastoma multiforme.


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